Single and Multiple Ascending Dose Study of AER-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-26

Study Completion Date

2024-08-31

Brief Summary

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This is a first-in-human, randomized, double-blind, placebo-controlled, Phase 1 study of AER-01 (solution for inhalation, delivered via nebulizer) to assess the safety, tolerability and PK of AER-01. The study will be conducted in 2 parts: a single ascending dose (SAD) part in HVs (Part A) and a 7-day multiple ascending dose (MAD) part in HVs(Part B).

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AER-01

Specified dose on specified days

Group Type EXPERIMENTAL

AER-01

Intervention Type DRUG

AER-01 solution for inhalation delivered via nebulizer

Placebo

Specified dose on specified days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for solution for inhalation delivered via nebulizer

Interventions

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AER-01

AER-01 solution for inhalation delivered via nebulizer

Intervention Type DRUG

Placebo

Placebo for solution for inhalation delivered via nebulizer

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers: Male or female aged ≥18 to ≤65 years.
* Current non-smoker or casual smoker Participants
* Females must not be pregnant or lactating

Exclusion Criteria

* History of unstable medical conditions or major surgical procedures over the 12 months prior to Screening.
* History or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic (excluding history of recurrent urinary tract infection), neurologic (excluding history of migraine), dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the PI or designee might obfuscate the study data.
* History of malignancy of any type, other than in situ cervical cancer or surgically excised non melanomatous skin cancers, within 5 years before Screening. Part B Participants with COPD and Moderate Airflow Limitation
* Has evidence of significant lung restriction on pulmonary function testing or a history of interstitial lung disease (including sarcoidosis and idiopathic pulmonary fibrosis), severe bronchiectasis, cystic fibrosis (asthma is not an exclusion.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes